Glossary

Serious Adverse Event (SAE)

February 27, 2012

According to FDA, an adverse event associated with the use of a medical product is considered serious and should be reported to the agency when the patient outcome results in: death, life-threatening condition, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, or intervention to prevent permanent impairment or damage.